In the pharmaceutical industry, the step of reconstituting a drug or other material is well known. Many pharmaceutical compositions are not capable of being stored for extended periods of time since their potency may change. In order to overcome this problem of a short shelf life, such pharmaceutical products are stored as a solid component and a liquid component. Prior to use, the two components must be mixed together.
Furthermore, while preservatives are effective in preserving some ingredients included in a pharmaceutical composition, such preservatives may cause adverse reactions with other ingredients of the pharmaceutical composition, namely the active ingredient, and result in degradation and/or spoilage. In some situations, refrigeration may be used to combat degradation or spoilage of a pharmaceutical composition. However, refrigeration is not always accessible and administration of a cooled pharmaceutical composition may reduce the effectiveness, namely solubility and penetration, of the pharmaceutical composition.
Although many reconstitution systems are directed for use with a powdered solid component and a diluent component, there are also occasions when other forms of material may be utilized. Thus, the reconstitution system may employ two liquids, or a semi liquid component such a paste along with a second component which is typically a liquid. Several problems must be addressed in any reconstitution device such as the problem of obtaining a proper mixture. For highly soluble products such as a powder and a diluent therefore, a simple mixing of the two components is sufficient. Typically in such an arrangement, the diluent and dry components are stored in separate compartments of a device. The device will include a by-pass such that pressure on a plunger will cause the liquid to go through the by-pass to mix with the dry ingredient. Usually a simple shaking of the mixture is sufficient to assure that the mixture is properly constituted.
However, certain pharmaceutical products require a more thorough mixing and the conventional devices cannot be used. One other problem which is frequently encountered is that the components to be mixed are utilized in a small quantity and conventional mixing devices are not suitable. This is particularly the case when one of the components is in the form of a paste into which a liquid like constituent must be mixed.
Furthermore, poor application of a pharmaceutical composition can hinder the effectiveness of the pharmaceutical composition. Some advances in the ergonomics and delivery of pharmaceutical compositions have been made, see for example U.S. Pat. No. 6,224,573 (Yeager et al.). However, previous applicators that combined more than one composition together prior to administration do not have sufficient mixing mechanisms to achieve optimal composition storage, mixing, and application. Thus, there remain needs for methods of treating and devices to overcome all the issues that remain with the storage, mixing, and administration of pharmaceutical compositions.